Recent posts

Mutagenic Impurity Risk Assessment Throughout the Development and Manufacturing Process

By September 15, 2020

Since the early 2000s and the advent of the first guidance relating to mutagenic impurities developed by the European Medicines Agency (EMA), it has been necessary to assess the risk posed by mutagenic impurities.  Although… Read more >

Categories: Pharmaceutical
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The Impact of Complex Global Supply on the Nitrosamine Crisis

By July 9, 2020

When a crisis occurs, hindsight is a great teacher. Any company developing or manufacturing products that impact human health can learn from the recent nitrosamine impurity contamination of angiotensin II receptor blockers (ARBs) by reviewing… Read more >

Categories: Pharmaceutical
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Navigating the Uncertainties of the Nitrosamine Impurity Crisis

By March 26, 2020

The nitrosamine impurity crisis continues to be on the mind of every stakeholder involved in the development and manufacturing of affected drug products. In our interactions with key opinion leaders and those in the lab having to develop and validate nitrosamine testing methods, we’ve come across a few common questions that we want to address here

Categories: Pharmaceutical
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Data Integrity Matters: Unknown, Unintegrated or Undetected Chromatography Peaks

By March 24, 2020

In an earlier blog, I discussed the concerns about extraneous peaks that might appear in LC separations. While there can be many sources for peaks unrelated to the test substances, how do you decide which… Read more >

Categories: Data Integrity
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Nitrosamine Impurities: The Need to Verify

By December 17, 2019

The recent nitrosamine impurity crisis has brought into question the quality of many APIs (Active Pharmaceutical Ingredients) produced and sourced for a number of popular drugs, resulting in product recalls, lost profits, and regulatory actions.… Read more >

Categories: Pharmaceutical
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Get Empowered: Another Reader Question on Quantitating Impurities | Tip #78

By July 18, 2018
Empower tip-of-the-week

Lots of questions about calculating impurities in Empower Software! Here’s another answer to a reader who inquired: How do you quantitate impurities against the main component? We’re happy to show how…

Categories: Empower Tips
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